Service Directory

Alternative and Complementary Medicine Renewal

This service allows beneficiaries to submit an application for the renewal of marketing authorization for alternative and complementary medicines, such as herbal products, traditional remedies, dietary supplements, and natural health products, once their initial approval period has expired. The renewal ensures that these products continue to meet safety, quality, and efficacy standards before remaining available on the market.

Service Conditions

Valid importer pharmacy license.

Required Attachments

Valid product registration license/Free sales certificate from country of origin (legalized) (with validity of at least 3 months and must mention the date of marketing)
Product composition certificate (including exact concentration, source & function of both active ingredient and excipient)
Mock-ups of outer label, inner label and package leaflet
Declaration letter from the company that the product is GMO free
Declaration letter from the company declaring the following: This product is free from hormones, heavy metals, antibiotics, steroids, pork and other animal origin derivatives, TSE and any other natural or synthetic material that have harmful effects on biochemical functions or behavior of human beings
Declaration for intended use
Declaration for Alcohol content
Lab file
Manufacturing process
Worldwide registration and marketing status with date of marketing
Declaration letter for contact details for the company person responsible for communication with NHRA on quality related matters
Copy of pharmacopeia reference
Application form
Copy of NHRA approval certificate (for renewal application only)
Valid pharmacy license with related activity.
Valid copy of manufacturing license of the manufacturer. (With validity of at least 3 months)
Valid Good Manufacturing Practice certificate (GMP) (legalized) (with validity of at least 3 months)

Legal Regulations

Ministerial Resolution No. (33) of 2016 regulating the practice of alternative and complementary medicine fields
Decree-Law No. (18) of 1997 regulating the profession of pharmacy and pharmaceutical centres
Decree-Law No. (18) of 1997 regulating the pharmacy profession and pharmaceutical centres